The statements in this background section merely provide background information related to the present disclosure and may not constitute prior art.
Various compositions and materials have been proffered in the past as being beneficial for treating the skin of human subjects that was exposed to intense heat and severely burned. Severe skin burns can result from direct exposure to heat, such as from when a person is trapped in a fire, or when their person is literally on fire, perhaps by virtue of having petrol or other hydrocarbon on their body, which somehow becomes ignited. Severe thermally-induced skin burns can also result from skin contact with hot liquids or solids, including without limitation liquids such as steam and hot oils, and hot solids such as red-hot iron and ceramics. Chemically-induced severe skin burns can result from contact with strong acids, strong alkalis, phenols, cresols and many other known inorganic and organic compounds. Deep tissue necrosis from chemical burns often results from chemical exposures. Severe burns to human skin can also result from skin exposure to electricity, including radio frequency (RF) energy.
Burns on human skin which are thermally-induced or caused by heat are classified into three types: first-degree skin burns, second-degree skin burns, and third-degree skin burns. It is recognized in the art that first-degree skin burns are those on the skin which are limited in depth to only the epidermis, and second-degree thermal skin burns (partial-thickness burns) are those which further involve damage to the papillary dermis. Second-degree thermal skin burns typically heal within about two weeks time, with little to no scarring. It is accepted in the art that the healing of second-degree burns occurs from epidermal cells that line or surround the sweat gland ducts and hair follicles, which cells grow towards the surface of the epidermis and towards other similarly growing cells from adjacent sweat gland ducts and hair follicles. Some second-degree burns can partially involve deeper layers of the dermis and require more than two weeks to heal, since, in such deeper second-degree burns, healing only occurs from the cells lining or surrounding the hair follicles.
Various topical treatments have been employed and marketed for treating first and second-degree thermal skin burns. Commonly-used remedies include simple soaking the affected area or burn wound in cold water, and topical application of various crémes, lotions, ointments, and the like. In some formulations, local anesthetics including without limitation lidocaine are present in a topical formulation applied directly to skin for relief from pain associated with the burned area. Some topical formulations include anti-biotics such as silver sulfadiazine; however, a few other known topical anti-biotic formulations have been employed. Another common remedy is for the person to systemically ingest a non-steroidal anti-inflammatory medicament, such as acetaminophen or ibuprofen. First-degree and second-degree burns typically heal on their own, with time.
Third-degree skin burns are a completely different story than first-degree or second-degree skin burns. Third-degree burns result in en masse protein denaturation and coagulative necrosis, mostly due to the brute-force effect of pyrolysis-like oxidative reactions caused to occur when an intense source of heat is acutely present in close proximity to, or contact with the skin. Third-degree burn scenarios are somewhat analogous to the situation in which cattle are branded with a red-hot branding iron, or the changes experienced by a corpse during the early moments of a cremation process.
By definition, third-degree burns extend entirely through all dermal layers and into the underlying muscular and/or fatty tissues. This results in the extreme complication whereby the body can only heal third-degree burns from the periphery of the damaged regions. For cases where substantial portions of the human body experiences third-degree burns, this often means that healing is not possible; i.e., when there is essentially no undamaged tissue adjacent to a third-degree burn area, healing cannot occur. For this reason, it is generally accepted in the medical arts that third-degree burns require excision (escharectomy) and skin grafting.
Medical personnel use the measure of Total Body Surface Area (TBSA) involvement, which is an estimation of the surface area of the body affected by burns, to quantitatively describe the extent to which the body of an individual has been burned. It is generally accepted in the art that for adult subjects, a TBSA in the range of between about 20 to 25% requires intravenous fluid resuscitation. It is also generally accepted that subjects who have experienced third-degree burns having a TBSA of between about 30 to 40% may be in a fatal situation, absent any treatment. Moreover, persons having bodily burns with a TBSA greater than about 40% are prone to develop systemic complications including hypovolemia, infections, hypoalbuminemia, electrolyte deficiencies, metabolic acidosis, rhabdomyolysis, hemolysis, hypothermia and ileus, among others.
Prior to the present invention, there has been no known effective topical medicament useful for inducing formation of granulation tissue in third-degree burns on human skin. The present invention is also applicable to all mammalian skin, using the same treatment specifications and/or regimens herein described.